Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a medical device including a remotely actuated cross-sectional adjustment mechanism. The medical device may include a cross-sectional adjustment mechanism configured to actuate an implantable medical device between a first dimension and a second dimension that is larger than a first dimension to adjust an amount of fluid flow through the implantable medical device.

Abstract: A diametrically adjustable endoprosthesis includes a controlled expansion element extending along at least a portion of a graft and is supported by a stent. The controlled expansion element diametrically constrains and limits expansion of the endoprosthesis. Upon deployment from a smaller, delivery configuration, the endoprosthesis can expand to the initial diameter set by the controlled expansion element. Thereafter, the endoprosthesis can be further diametrically expanded (e.g., using balloon dilation) by mechanically altering the controlled expansion element.

Abstract: The present disclosure comprises devices, systems, and methods having an inverted sheath configured to cover, and in some instances constrain, a medical device and to retract through eversion, thus enabling the deployment of medical device at the treatment site. A constraining sheath can evert hydraulically. A constraining sheath can be configured to neck down a medical device to achieve a lower delivery profile. Furthermore, a constraining sheath can comprise a balloon to expand or positionally or structurally adjust a medical device.

Abstract: An additive manufacturing process is provided to produce integral 3-dimensional (3D) articles by laminating together a plurality of expanded polytetrafluoroethylene (ePTFE) membranes. The process includes repetitive cycles of ePTFE membrane lamination paired with laser cutting/bonding to produce a desired geometry based on a predefined pattern.

Abstract: A multi lumen catheter assembly. The assembly provides an expandable, low profile, fixed length sheath and catheter, with fixed infusion ports. The assembly has an expandable outer sheath that expands upon pressure activation with a fluid and the sheath allows the fluid to exit from at least one predetermined fixed location from a distal end of the catheter assembly. The catheter assembly can be used in various medical device procedures, such as a TIPS (Transjugular Intrahepatic Portosystemic Shunt) procedure, or anywhere a low profile, multi lumen, infusion catheter system is desired.

Abstract: A thrombus treatment device includes a support wire, a body frame portion that is disposed about an axis defined by the support wire, one or more tethers that each have a first end and a second end, and a filter element extending from the body frame portion. Each of the one or more tethers is attached at its first end to the body frame portion, and at its second end to a collar that couples the second end of each of the multiple tethers to the support wire. When the collar is positioned substantially within a region interior of the body frame portion, a rotational actuation of the support wire causes a swiveling motion of the one or more tethers.

Abstract: A stent incorporating flexible, preferably polymeric, connecting elements into the stent wherein these elements connect adjacent, spaced-apart stent elements. Preferably the spaced-apart adjacent stent elements are the result of forming the stent from a helically wound serpentine wire having space provided between adjacent windings. Other stent forms such as multiple, individual spaced-apart ring-shaped or interconnected stent elements may also be used. The connecting elements are typically web-shaped and result from creating slits or apertures in a covering of graft material applied to the stent and then, for example, applying heat to cause the slits or apertures to enlarge. The remaining graft material forms the interconnecting webs between the adjacent stent elements.

Abstract: An endoluminal access device including an outer sheath defining a lumen and a guide assembly. The guide assembly includes an expandable portion configured to be transitioned between a collapsed configuration having a first diameter and an expanded configuration having a second diameter that is greater than the first diameter. The expandable portion includes a first arm defining a first lumen and an aperture in communication with the first lumen. The expandable portion is configured to expand outwardly from a central longitudinal axis when the expandable portion transitions to the expanded configuration and to deflect inwardly toward the central longitudinal axis when the expandable portion is transitioned to the collapsed configuration. The endoluminal access device further includes an endoluminal tool deliverable from the first lumen of the first arm and outwardly from the aperture of the first arm.

Abstract: A multi lumen catheter assembly. The assembly provides an expandable, low profile, fixed length sheath and catheter, with fixed infusion ports. The assembly has an expandable outer sheath that expands upon pressure activation with a fluid and the sheath allows the fluid to exit from at least one predetermined fixed location from a distal end of the catheter assembly. The catheter assembly can be used in various medical device procedures, such as a TIPS (Transjugular Intrahepatic Portosystemic Shunt) procedure, or anywhere a low profile, multi lumen, infusion catheter system is desired.

Abstract: The present disclosure is directed toward composite materials comprising high aspect ratio habits of drug crystals which can be partially or fully extending into a substrate, and additionally, can be projecting from a substrate at an angle of about 20° to about 90°. The present disclosure is directed toward medical devices, such as medical balloons, comprising said composite and methods of using and making the same. The described composite can be used for the local treatment of vascular disease. The present disclosure is also directed toward paclitaxel crystals with a hollow acicular habit.

Abstract: An implantable containment apparatus for receiving and retaining a biological moiety, including a plurality of cells, for insertion into a patient, such as into a tissue bed, is disclosed. The device includes a cell encapsulating pouch that forms and interior volume having a reservoir space for receiving cells, where the reservoir space includes first and second interior surfaces, and a tensioning member to maintain an average distance between the first interior surface and the second interior surface.

Abstract: An implantable medical device for altering blood flow in a vessel of a patient, the device including a stent element and a graft component attached to at least a portion of the stent element. The stent element and the graft component include a restricting portion configured to direct flow into one or more side branches off the vessel, and an anchor portion to arrange an inlet of the restricting portion approximately centrally within the vessel.

Abstract: A stent graft including a stent having a wall having at least one opening, an outer surface, and an inner surface and a covering of a composite material having a least one expanded fluoropolymer membrane and an elastomer is provided. The cover can be used to cover the outer and/or the inner surface of the stent. The expanded fluoropolymer membrane contains serpentine fibrils. In exemplary embodiments, the fluoropolymer is polytetrafluoroethylene. The composite material may be axially and/or circumferentially wrapped around the stent. The composite material is fold-free throughout its operating diameter range and exhibits a sharp increase in stiffness at a predetermined diameter. The stent graft can be designed to have a stop point in either a radial or axial direction. The stent graft can advantageously be implanted undersized with respect to a nominal diameter without having material infolding.

Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: A stent incorporating flexible, preferably polymeric, connecting elements into the stent wherein these elements connect adjacent, spaced-apart stent elements. Preferably the spaced-apart adjacent stent elements are the result of forming the stent from a helically wound serpentine wire having space provided between adjacent windings. Other stent forms such as multiple, individual spaced-apart ring-shaped or interconnected stent elements may also be used. The connecting elements are typically web-shaped and result from creating slits or apertures in a covering of graft material applied to the stent and then, for example, applying heat to cause the slits or apertures to enlarge. The remaining graft material forms the interconnecting webs between the adjacent stent elements.

Abstract: The present invention is directed to a deployment system for an endoluminal device. The deployment system includes a confining sheath placed around a compacted endoluminal device. A deployment line is provided in the system. As the deployment line is actuated, the sheath retracts from around the compacted endoluminal device. Once the sheath is retracted from around the compacted endoluminal device, the endoluminal device is operable to expand. Any remaining sheath material is removed from the implantation site along with the deployment line.

Abstract: Implantable grafts, particularly for arteriovenous access that may be punctured by an object such as a needle and, following removal of the object, will reseal the resulting hole to the extent of reducing fluid leakage through the graft at the puncture site to an amount less than would be typical for a conventional graft. More particularly, the grafts comprise three layers; an inner layer of implantable graft material such as ePTFE, a middle layer of self sealing elastomeric material such as silicone, and an outer layer of implantable graft material such as ePTFE. Following manufacture, the tubular form of the three-layer graft is everted to put substantially the entire wall thickness of the elastomeric material layer under circumferential compression.

Abstract: The present disclosure describes a system and method for securing medical devices to the tissue of a patient using one or more anchors. Anchors can be independent from or integral to the medical device deployed within the patient. Such anchors are configured to engage and maintain contact with the tissue using a tissue-penetrating point and bendable shaft.

Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: Various embodiments provide a device comprising a balloon assembly including a balloon, a film template, and a rigid element. The film template may have a fixed upper distension limit and may include at least one aperture. The rigid element may lay substantially flush with an outer surface of the balloon at a first inflated state of the balloon. The first upper distension limit of the balloon may be greater than the fixed upper distension limit of the film template and the balloon may outwardly protrude through the at least one aperture at a second inflated state. The rigid element may be extended in a radial direction away from the outer surface of the balloon as the balloon outwardly protrudes through the at least one aperture relative to the outer surface of the film template.